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Process Development Definition | Law Insider Define Process Development. means all process development activities undertaken with respect to Products, including without limitation activities related to development and optimization of cell lines, expression systems, reagents, upstream process, downstream process, protein modification, development of the Manufacturing process, process scale-up, process characterization, and process validation for bulk drug substance and final dosage forms of the Products and their related placebos. <dfn>Process Development</dfn> <!-- -->means all <a href=""/clause/process-development-activities"" rel="“noopener noreferrer”" target=""_blank"">process development activities</a> <a href=""/dictionary/undertaken"" rel="“noopener noreferrer”" target=""_blank"">undertaken</a> <a href=""/clause/with-respect-to"" rel="“noopener noreferrer”" target=""_blank"">with respect to</a> Products, <a href=""/clause/including-without-limitation"" rel="“noopener noreferrer”" target=""_blank"">including without limitation</a> activities related <a href=""/clause/to-development"" rel="“noopener noreferrer”" target=""_blank"">to development</a> and <a href=""/clause/optimization"" rel="“noopener noreferrer”" target=""_blank"">optimization</a> of <a href=""/clause/cell-lines"" rel="“noopener noreferrer”" target=""_blank"">cell lines</a>, <a href=""/clause/expression"" rel="“noopener noreferrer”" target=""_blank"">expression</a> <a href=""/clause/systems"" rel="“noopener noreferrer”" target=""_blank"">systems</a>, <a href=""/clause/reagents"" rel="“noopener noreferrer”" target=""_blank"">reagents</a>, <a href=""/dictionary/upstream-process"" rel="“noopener noreferrer”" target=""_blank"">upstream process</a>, <a href=""/dictionary/downstream-process"" rel="“noopener noreferrer”" target=""_blank"">downstream process</a>, <a href=""/clause/protein"" rel="“noopener noreferrer”" target=""_blank"">protein</a> <a href=""/clause/modification"" rel="“noopener noreferrer”" target=""_blank"">modification</a>, <a href=""/clause/development-of-the"" rel="“noopener noreferrer”" target=""_blank"">development of the</a> <a href=""/clause/manufacturing-process"" rel="“noopener noreferrer”" target=""_blank"">Manufacturing process</a>, process <a href=""/clause/scale"" rel="“noopener noreferrer”" target=""_blank"">scale</a>-up, process <a href=""/clause/characterization"" rel="“noopener noreferrer”" target=""_blank"">characterization</a>, and <a href=""/clause/process-validation"" rel="“noopener noreferrer”" target=""_blank"">process validation</a> for <a href=""/clause/bulk-drug-substance"" rel="“noopener noreferrer”" target=""_blank"">bulk drug substance</a> and <a href=""/clause/final"" rel="“noopener noreferrer”" target=""_blank"">final</a> <a href=""/dictionary/dosage-forms"" rel="“noopener noreferrer”" target=""_blank"">dosage forms</a> of <a href=""/clause/the-products"" rel="“noopener noreferrer”" target=""_blank"">the Products</a> and their related placebos. Based on 6 documents <dfn>Process Development</dfn> <!-- -->means all <a href=""/clause/process-development-activities"" rel="“noopener noreferrer”" target=""_blank"">process development activities</a> <a href=""/dictionary/undertaken"" rel="“noopener noreferrer”" target=""_blank"">undertaken</a> <a href=""/clause/with-respect-to"" rel="“noopener noreferrer”" target=""_blank"">with respect to</a> <a href=""/clause/the-product"" rel="“noopener noreferrer”" target=""_blank"">the Product</a>, <a href=""/clause/including"" rel="“noopener noreferrer”" target=""_blank"">including</a> <a href=""/clause/activities-related-to"" rel="“noopener noreferrer”" target=""_blank"">activities related to</a> []. [] <a href=""/clause/certain-information"" rel="“noopener noreferrer”" target=""_blank"">Certain information</a> in this <a href=""/clause/document"" rel="“noopener noreferrer”" target=""_blank"">document</a> has been <a href=""/clause/omitted-and-filed-separately-with-the-securities-and-exchange-commission"" rel="“noopener noreferrer”" target=""_blank"">omitted and filed separately with the Securities and Exchange Commission</a>. <a href=""/clause/confidential-treatment"" rel="“noopener noreferrer”" target=""_blank"">Confidential treatment</a> has been <a href=""/clause/requested"" rel="“noopener noreferrer”" target=""_blank"">requested</a> with respect to the omitted <a href=""/clause/portions"" rel="“noopener noreferrer”" target=""_blank"">portions</a>. Based on 3 documents <dfn>Process Development</dfn> <!-- -->means all <a href=""/clause/process-development-activities"" rel="“noopener noreferrer”" target=""_blank"">process development activities</a> <a href=""/dictionary/undertaken"" rel="“noopener noreferrer”" target=""_blank"">undertaken</a> <a href=""/clause/with-respect-to"" rel="“noopener noreferrer”" target=""_blank"">with respect to</a> <a href=""/clause/the-product"" rel="“noopener noreferrer”" target=""_blank"">the Product</a>, <a href=""/clause/including"" rel="“noopener noreferrer”" target=""_blank"">including</a> <a href=""/clause/activities-related-to"" rel="“noopener noreferrer”" target=""_blank"">activities related to</a> []. “<a href=""/clause/process-development-costs"" rel="“noopener noreferrer”" target=""_blank"">Process Development Costs</a>” means <a href=""/dictionary/all-costs"" rel="“noopener noreferrer”" target=""_blank"">all costs</a> <a href=""/dictionary/invoiced"" rel="“noopener noreferrer”" target=""_blank"">invoiced</a> <a href=""/clause/by-third-parties"" rel="“noopener noreferrer”" target=""_blank"">by Third Parties</a> to <a href=""/clause/coherus"" rel="“noopener noreferrer”" target=""_blank"">Coherus</a> <a href=""/clause/and-or"" rel="“noopener noreferrer”" target=""_blank"">and/or</a> its <a href=""/clause/affiliates"" rel="“noopener noreferrer”" target=""_blank"">Affiliates</a> for Process Development activities <a href=""/clause/after-the-effective-date"" rel="“noopener noreferrer”" target=""_blank"">after the Effective Date</a> <a href=""/dictionary/directly"" rel="“noopener noreferrer”" target=""_blank"">directly</a> <a href=""/dictionary/resulting-from"" rel="“noopener noreferrer”" target=""_blank"">resulting from</a> any Process <a href=""/clause/development-efforts"" rel="“noopener noreferrer”" target=""_blank"">Development efforts</a> as <a href=""/dictionary/set-forth"" rel="“noopener noreferrer”" target=""_blank"">set forth</a> in the <a href=""/clause/process-development-plan"" rel="“noopener noreferrer”" target=""_blank"">Process Development Plan</a> or otherwise <a href=""/clause/approved-by"" rel="“noopener noreferrer”" target=""_blank"">approved by</a> <a href=""/clause/the-jsc"" rel="“noopener noreferrer”" target=""_blank"">the JSC</a>. Process Development Costs shall <a href=""/clause/include"" rel="“noopener noreferrer”" target=""_blank"">include</a> [], such as []. <a href=""/clause/for-the-avoidance-of-doubt"" rel="“noopener noreferrer”" target=""_blank"">For the avoidance of doubt</a>, <a href=""/clause/the-term"" rel="“noopener noreferrer”" target=""_blank"">the term</a> ‘Process Development Costs’ shall include []. Based on 2 documents <dfn>Process Development</dfn> <!-- -->shall be <a href=""/dictionary/deemed"" rel="“noopener noreferrer”" target=""_blank"">deemed</a> to be <a href=""/dictionary/initiated"" rel="“noopener noreferrer”" target=""_blank"">initiated</a>, <a href=""/clause/with-respect-to-a"" rel="“noopener noreferrer”" target=""_blank"">with respect to a</a> <a href=""/clause/particular"" rel="“noopener noreferrer”" target=""_blank"">particular</a> <a href=""/dictionary/ta"" rel="“noopener noreferrer”" target=""_blank"">TA</a> <a href=""/clause/library"" rel="“noopener noreferrer”" target=""_blank"">Library</a>, at such <a href=""/clause/time"" rel="“noopener noreferrer”" target=""_blank"">time</a> as <a href=""/clause/synthetic"" rel="“noopener noreferrer”" target=""_blank"">synthetic</a> <a href=""/clause/feasibility-studies"" rel="“noopener noreferrer”" target=""_blank"">feasibility studies</a> used to define an <a href=""/dictionary/efficient"" rel="“noopener noreferrer”" target=""_blank"">efficient</a> synthetic <a href=""/clause/process"" rel="“noopener noreferrer”" target=""_blank"">process</a> for <a href=""/clause/production-of"" rel="“noopener noreferrer”" target=""_blank"">production of</a> such TA Library have been <a href=""/clause/commenced"" rel="“noopener noreferrer”" target=""_blank"">commenced</a>. Based on 2 documents <dfn>Process Development</dfn> <!-- -->means <a href=""/clause/the-period"" rel="“noopener noreferrer”" target=""_blank"">the period</a> <a href=""/clause/commencing"" rel="“noopener noreferrer”" target=""_blank"">commencing</a> with a <a href=""/clause/processing"" rel="“noopener noreferrer”" target=""_blank"">processing</a> <a href=""/clause/run"" rel="“noopener noreferrer”" target=""_blank"">run</a> using <a href=""/clause/the-working"" rel="“noopener noreferrer”" target=""_blank"">the Working</a> <a href=""/clause/seed"" rel="“noopener noreferrer”" target=""_blank"">Seed</a> and <a href=""/clause/ending"" rel="“noopener noreferrer”" target=""_blank"">ending</a> on <a href=""/clause/validation"" rel="“noopener noreferrer”" target=""_blank"">Validation</a>; Based on 2 documents <dfn>Process Development</dfn> <!-- -->means the <a href=""/clause/exploration"" rel="“noopener noreferrer”" target=""_blank"">exploration</a>, <a href=""/clause/identification"" rel="“noopener noreferrer”" target=""_blank"">identification</a>, <a href=""/clause/development-and-scale"" rel="“noopener noreferrer”" target=""_blank"">development and scale</a>-up, pursuant to a <a href=""/clause/statement-of-work"" rel="“noopener noreferrer”" target=""_blank"">Statement of Work</a>, of (i) one or more new or <a href=""/dictionary/improved"" rel="“noopener noreferrer”" target=""_blank"">improved</a> <a href=""/clause/synthetic-pathways"" rel="“noopener noreferrer”" target=""_blank"">Synthetic Pathways</a> <a href=""/clause/for-manufacturing"" rel="“noopener noreferrer”" target=""_blank"">for manufacturing</a> <a href=""/dictionary/oled-chemicals"" rel="“noopener noreferrer”" target=""_blank"">OLED Chemicals</a> in <a href=""/clause/quantities"" rel="“noopener noreferrer”" target=""_blank"">quantities</a> <a href=""/dictionary/sufficient"" rel="“noopener noreferrer”" target=""_blank"">sufficient</a> <a href=""/clause/for-supply"" rel="“noopener noreferrer”" target=""_blank"">for supply</a> on a <a href=""/dictionary/commercial-scale"" rel="“noopener noreferrer”" target=""_blank"">commercial scale</a> and on a <a href=""/clause/cost"" rel="“noopener noreferrer”" target=""_blank"">cost</a>-<a href=""/clause/effective"" rel="“noopener noreferrer”" target=""_blank"">effective</a> <a href=""/clause/basis"" rel="“noopener noreferrer”" target=""_blank"">basis</a>, <a href=""/clause/including"" rel="“noopener noreferrer”" target=""_blank"">including</a> any <a href=""/clause/processes"" rel="“noopener noreferrer”" target=""_blank"">processes</a> <a href=""/clause/intended"" rel="“noopener noreferrer”" target=""_blank"">intended</a> <a href=""/clause/to-qualify"" rel="“noopener noreferrer”" target=""_blank"">to qualify</a> as <a href=""/clause/validated"" rel="“noopener noreferrer”" target=""_blank"">Validated</a> Processes; (ii) new or improved <a href=""/clause/material-specifications"" rel="“noopener noreferrer”" target=""_blank"">Material Specifications</a> for such OLED Chemicals; and (<a href=""/clause/iii"" rel="“noopener noreferrer”" target=""_blank"">iii</a>) new or improved <a href=""/clause/analytical"" rel="“noopener noreferrer”" target=""_blank"">analytical</a> <a href=""/clause/methodologies"" rel="“noopener noreferrer”" target=""_blank"">methodologies</a>, data and <a href=""/clause/data-analyses"" rel="“noopener noreferrer”" target=""_blank"">data analyses</a> for characterizing such OLED Chemicals. Based on 2 documents <dfn>Process Development</dfn> <!-- -->means <a href=""/clause/with-respect-to-a"" rel="“noopener noreferrer”" target=""_blank"">with respect to a</a> Product, all activities related <a href=""/dictionary/to-process"" rel="“noopener noreferrer”" target=""_blank"">to process</a> <a href=""/clause/development-of"" rel="“noopener noreferrer”" target=""_blank"">development of</a> API or Product, <a href=""/clause/including"" rel="“noopener noreferrer”" target=""_blank"">including</a> the(a) raw <a href=""/clause/materials-selection"" rel="“noopener noreferrer”" target=""_blank"">materials selection</a>, (b) <a href=""/clause/manufacturing-development"" rel="“noopener noreferrer”" target=""_blank"">manufacturing development</a>, © test <a href=""/clause/method-development"" rel="“noopener noreferrer”" target=""_blank"">method development</a> of raw materials, (d) in-process products, (e) <a href=""/dictionary/intermediate-products"" rel="“noopener noreferrer”" target=""_blank"">intermediate products</a>, <a href=""/clause/api-and-product"" rel="“noopener noreferrer”" target=""_blank"">API and Product</a>, (f) <a href=""/clause/formulation-development"" rel="“noopener noreferrer”" target=""_blank"">formulation development</a>, (g) <a href=""/clause/stability-studies"" rel="“noopener noreferrer”" target=""_blank"">stability studies</a> of raw material, <a href=""/clause/buffers"" rel="“noopener noreferrer”" target=""_blank"">buffers</a>, <a href=""/clause/intermediates"" rel="“noopener noreferrer”" target=""_blank"">intermediates</a> products, API and Product, (h) <a href=""/dictionary/viral"" rel="“noopener noreferrer”" target=""_blank"">viral</a> <a href=""/clause/safety"" rel="“noopener noreferrer”" target=""_blank"">safety</a> <a href=""/clause/steps"" rel="“noopener noreferrer”" target=""_blank"">steps</a> <a href=""/clause/development-and-validation"" rel="“noopener noreferrer”" target=""_blank"">development and validation</a>, (i) process <a href=""/clause/robustness"" rel="“noopener noreferrer”" target=""_blank"">robustness</a> and <a href=""/clause/process-validation"" rel="“noopener noreferrer”" target=""_blank"">process validation</a>, (j) analytical <a href=""/clause/method-validation"" rel="“noopener noreferrer”" target=""_blank"">method validation</a> for <a href=""/clause/quality-controls"" rel="“noopener noreferrer”" target=""_blank"">quality controls</a> of raw materials, intermediates, API and Product, (k) <a href=""/clause/shipment"" rel="“noopener noreferrer”" target=""_blank"">shipment</a> validation, (l) <a href=""/clause/container"" rel="“noopener noreferrer”" target=""_blank"">container</a> <a href=""/clause/closure"" rel="“noopener noreferrer”" target=""_blank"">closure</a> <a href=""/clause/study"" rel="“noopener noreferrer”" target=""_blank"">study</a>, (m) leachable and extractable study, (n) <a href=""/clause/cleaning"" rel="“noopener noreferrer”" target=""_blank"">cleaning</a> development and validation, (o) <a href=""/clause/column"" rel="“noopener noreferrer”" target=""_blank"">column</a> <a href=""/clause/lifetime"" rel="“noopener noreferrer”" target=""_blank"">lifetime</a> study, § <a href=""/clause/filing"" rel="“noopener noreferrer”" target=""_blank"">filing</a> <a href=""/clause/support"" rel="“noopener noreferrer”" target=""_blank"">support</a> for <a href=""/clause/regulatory-submissions"" rel="“noopener noreferrer”" target=""_blank"">regulatory submissions</a>. Based on 1 documents <dfn>Process Development</dfn> <!-- -->means, <a href=""/clause/with-respect-to-a"" rel="“noopener noreferrer”" target=""_blank"">with respect to a</a> <a href=""/clause/product"" rel="“noopener noreferrer”" target=""_blank"">product</a>, all process development, <a href=""/clause/process-improvements"" rel="“noopener noreferrer”" target=""_blank"">process improvements</a>, <a href=""/clause/manufacturing-scale"" rel="“noopener noreferrer”" target=""_blank"">manufacturing scale</a>-up, <a href=""/clause/qualification-and-validation"" rel="“noopener noreferrer”" target=""_blank"">qualification and validation</a> and <a href=""/clause/quality-assurance"" rel="“noopener noreferrer”" target=""_blank"">quality assurance</a>/<a href=""/clause/quality-control"" rel="“noopener noreferrer”" target=""_blank"">quality control</a> with respect to such product. Based on 1 documents

Note: pulled this data out of the SEC EDGAR Database of 500,000 records from the past 22 years of filings. We regularly update this page as new filings and definitions come in.

yourself to verify these results. We are always keen to point people to source documents.

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Which definition should you use?

🤔 has combined and improved the above descriptions to create market-standard '������ý definitions' below, with guidance on which documents and which industry to use for each.

������ý Definition 1

• Process Development means all activities related to the creation, improvement, scale-up, and validation of systematic procedures related to a product or service.

Relevant Contract Types

• Product Development Agreement
• Manufacturing Agreement
• Supply Chain Management Agreement
• Service Level Agreement
• Consulting Agreement

Relevant Circumstances

• Scaling a manufacturing process
• Developing a new product line
• Implementing process improvements
• Quality assurance and control

Relevant Sectors

• Pharmaceuticals
• Manufacturing
• Biotechnology

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